The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke

NCT ID: NCT07253519

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-20

Study Completion Date

2025-11-30

Brief Summary

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This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Patients' functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index, while ambulation status will be documented with the Holden Scale. Caregivers will complete the Insomnia Severity Index to assess the severity of sleep disturbances and the Hospital Anxiety and Depression Scale to evaluate anxiety and depressive symptoms. Caregiver burden will be measured using the Zarit Caregiver Burden Scale. The study aims to investigate the relationship between caregivers' mood, insomnia severity, and caregiver burden.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years.
* Clinical diagnosis of stroke (ischemic or hemorrhagic; first-ever or recurrent).
* Ability of both the patient and caregiver to communicate in Turkish and participate in evaluations (mRS, Brunnstrom, Modified Barthel Index, Holden).
* Caregiver must have been the primary caregiver for the patient for at least 1 month.
* Willingness of both the patient and caregiver to participate in the study.

Exclusion Criteria

* History of subarachnoid hemorrhage.
* Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
* Terminal illness (life expectancy \< 6 months).
* Inability to reliably complete questionnaires due to a psychiatric disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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istftrrrr

Identifier Type: -

Identifier Source: org_study_id

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